Drug information of Capmatinib

Capmatinib


Capmatinib is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Capmatinib is used only if your cancer has a specific genetic marker (an abnormal "MET" gene). Your doctor will test you for this gene.

Capmatinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to capmatinib, but further studies are needed.

Mechanism of effect

Capmatinib is a potent and highly-selective inhibitor of mesenchymal-epithelial transition (MET), including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in increased downstream MET signaling. Through MET inhibition, capmatinib decreases cancer cell growth. Capmatinib inhibits MET phosphorylation triggered by binding of c-MET (also known as hepatocyte growth factor) or by MET amplification, as well as MET-mediated phosphorylation of downstream signaling proteins.

Pharmacokinetics

Absorption

>70%.

Distribution

Vdss: 164 L.

Metabolism

Primarily hepatic via CYP3A4 and aldehyde oxidase.

Excretion

Feces: 78% (42% as unchanged drug); urine: 22% (primarily as metabolites).

Clearance: 24 L/hour.

Time to Peak

~1 to 2 hours.

Half-Life Elimination

6.5 hours.

Protein Binding

96%.

Drug indications

Non-small cell lung cancer, metastatic: Treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an approved test.

Dosage

Usual Adult Dose for Non-Small Cell Lung Cancer

400 mg orally 2 times daily

Drug contraindications

There are no contraindications listed in the manufacturer's labeling.

Side effects

 Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or worsening cough, chest pain, trouble breathing;
  • fever, cough with mucus;
  • severe ongoing nausea and vomiting; or
  • liver problems--swelling around your midsection, right-sided upper stomach pain, vomiting, confusion, weakness, loss of appetite, dark urine, clay-colored stools, jaundice(yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • trouble breathing;
  • nausea, vomiting, decreased appetite;
  • feeling weak or tired;
  • abnormal liver function tests; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Points of recommendation

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

 


Tell your doctor if you have ever had:

  • lung problems other than lung cancer; or
  • liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using capmatinib should use effective birth control to prevent pregnancy. Capmatinib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using capmatinib.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take capmatinib with or without food.

You will need frequent blood tests to check your liver function.

Do not change your dose or stop taking this medicine without your doctor's advice.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking capmatinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Throw away any tablets that are left 6 weeks after you first opened the bottle.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Pregnancy level

HAVE NOT BEEN ESTABLISHED

Use is not recommended.

US FDA pregnancy category: Not assigned

Drug forms

Tabrecta

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